Persson 2000

Methods	RCT comparing 1 bilateral double‐bite Gore‐Tex suture to 2 bilateral single‐bite Gore‐Tex sutures in laparoscopic colposuspension Randomisation 1:1 F/U: 2/12 telephone interview, 1‐year clinic visit
Participants	161 women Inclusion criteria: bothersome stress incontinence symptoms, normal urethral closing pressure, hypermobility bladder neck, objective sign of leaking (pad test), stress incontinent with concomitant subdominant urge symptoms without associated urine leakage Exclusion criteria: urge incontinence, stress incontinence due to low urethral closing pressure (< 20 mm H2O), uterovaginal descent more than grade 1 cystocele, incontinence after previous vaginal repair, recurrent incontinence, high risk for GA or surgical complications
Interventions	Group 1 (n = 78): 1 bilateral double‐bite suture group 2 (n = 83): 2 bilateral single‐bite sutures Transperitoneal approach, vaginal fascia fixed against Cooper's ligament with sutures placed approx 2 cm lateral to each side of urethra and 2 cm distal to bladder neck Last 84 women received 2 g intravenous cefoxitin at induction Additional surgery in 63 cases (34 in group 1, 29 in group 2) Indwelling catheter, removed within 24 h post‐op and residuals recorded, if residual < 125 mLs discharge home, remaining women were offered delayed discharge, discharge with indwelling catheter or discharge with intermittent self‐catheterisation
Outcomes	Main objective outcome variables: leakage on ultrashort pad test, operation time Secondary objective outcome variables: post‐op voiding difficulties, complications during and after surgery, EBL Objective cure defined as no leaking at ultrashort pad test, improvement max. 1/3 of pre‐op leaking volume on pad test, unimproved > 1/3 of pre‐op leaking volume on pad test Subjective: women's description of cure, improvement, non‐improvement
Notes	Study set up to enrol 280 participants, trialists became convinced during F/U that 2 bilateral sutures have higher cure rate and therefore did an interim analysis on objective 1‐year cure rate on 108 participants, which showed a cure rate of 87% in group 2 vs 68% in group 1, therefore further enrolment into the study was stopped and only already enrolled participants were followed up; Losses to F/U: 1 in group 1, 2 in group 2; 9 women refused F/U pad test Minor adverse events only
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate